Diffuse large B-cell lymphoma: reimbursement approved for the first bispecific antibody administered subcutaneously

The drug will be reimbursed by the National Health Service Epcoritamabthe first and only bispecific antibody that can be administered subcutaneously in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) to two or more lines of systemic therapy.
This is the most common of the aggressive forms of Non-Hodgkin’s lymphoma and represents approximately 30% of all cases, with approximately 150,000 new patients estimated every year globally, of which 4,400 in Italy alone.

“For a long time, patients with R/R DLBCL had no viable treatment options,” he explained Pierluigi Zinzani, Full Professor of Hematology, Institute of Hematology “L. and A. Seràgnoli”, University of Bologna. «In recent years the therapeutic landscape has changed considerably with the arrival of new drugs or combinations of drugs without chemotherapy. Among these, epcoritamab represents an important novelty, it is a bispecific IgG1 antibody that derives from a humanized mouse anti-CD3 antibody and a monoclonal anti-human CD20 antibody. The formation of the epcoritamab-CD20-CD3 trimer determines the activation and expansion of T cells and the killing, mediated by T cells, of CD20+ tumor B cells.”

The Cure keyboardist Roger O’Donnell reveals he has a “very rare and aggressive” form of lymphoma. And he urges prevention
In a social post, the 68-year-old London musician explained to fans that over the last year he has undergone treatment to defeat a type of blood cancer that originates in the lymphatic system

The reimbursement approval by AIFA was achieved thanks to the data from the phase 1/2, open-label, multi-cohort, multi-centre, single-arm EPCORE™ NHL-1 study which evaluated the efficacy and safety profile of epcoritamab administered to patients with relapsed or refractory large B-cell lymphoma, including its subtype DLBCL. In this study, the 139 patients recruited achieved an overall response rate of 62% and a complete response rate of 39%.

«In my personal experience with epcoritamab in recent years, both in clinical studies and now in clinical practice, I have been able to verify that the drug is an accessible, highly effective treatment, readily available in a rapidly evolving pathology, easy to administer as it is subcutaneous and above all well tolerated,” he said Umberto Vitolo, Responsible for haematological clinical trials at the Candiolo Oncology Institute, Piedmont Foundation for Oncology, IRCCS, Candiolo (Turin).

Adverse effects under control

«Patients with large B-cell non-Hodgkin lymphoma with aggressive histology who relapse after current standard therapies (immunochemotherapy and CAR-T) have an important therapeutic need as they develop a rapidly evolving aggressive disease that hardly responds to current therapies» , he declares Maurizio Martelli, Full Professor of Hematology, Sapienza University of Rome. «The new bispecific monoclonal antibody epcoritamab has proven to be a valid therapeutic option with complete response rates in post CAR-T patients. In addition to these significant data regarding efficacy, the study demonstrated an improvement in quality of life parameters and a favorable safety profile. The most common adverse event observed was cytokine release syndrome (CRS) which in almost all cases was grade 1-2 which was found to be predictable in terms of onset times and easily manageable without leading to the suspension of treatment”.

Availability throughout Italy

«We will work to ensure that all eligible patients can easily access this therapeutic innovation throughout Italy, collaborating with Patient Associations, Scientific Societies, Institutions and Treatment Centers», he specifies. Fabrizio GrecoCEO of AbbVie Italia. «Our company has long been committed to the field of hematology to develop therapeutic solutions that can make a difference in patients’ lives. AIFA’s approval of reimbursement of epcoritamab represents a particularly significant milestone in strengthening our ambition to improve the standards of care in the management of various haematological malignancies, where the need and urgency of treatment remain high.”

Source: Vanity Fair

You may also like